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Treatment of Multiple Attacks of Acute Migraine (0462-025)

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ClinicalTrials.gov Identifier: NCT00899379
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : July 15, 2010
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine Headache
Interventions Drug: rizatriptan benzoate
Drug: Comparator: Placebo
Enrollment 473
Recruitment Details

Patients were recruited at 23 sites in the United States.

First Patient Treated: April, 1995

Last Patient Treated: January 1996

Pre-assignment Details Patients screened at a pretreatment visit were given allocated drug supply with instructions. If by 2 months after screening, a patient still had not treated a migraine attack with test medication, he/she was to be discontinued from the study.
Arm/Group Title Placebo/Rizatriptan/Rizatriptan/Rizatriptan Rizatriptan/Placebo/Rizatriptan/Rizatriptan Rizatriptan/Rizatriptan/Placebo/Rizatriptan Rizatriptan/Rizatriptan/Rizatriptan/Placebo Rizatriptan/Rizatriptan/Rizatriptan/Rizatriptan
Hide Arm/Group Description Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches) Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches) Rizatriptan 10 mg/Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches) Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Placebo = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches) Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
Period Title: Overall Study
Started 95 [1] 95 [1] 95 [1] 94 [1] 94 [1]
Patients Treated 83 [2] 82 [2] 84 [2] 77 [2] 81 [2]
Patients Not Treated 12 [3] 13 [3] 11 [3] 17 [3] 13 [3]
Completed 61 [4] 66 [4] 66 [4] 57 [4] 63 [4]
Not Completed 34 29 29 37 31
Reason Not Completed
Adverse Event             2             2             1             1             2
Lack of Efficacy             0             4             3             0             1
Lost to Follow-up             9             3             0             6             2
Protocol Violation             0             0             1             1             0
Withdrawal by Subject             2             4             2             3             6
Pregnancy             0             0             1             0             1
Patient Uncooperative             0             1             0             1             2
Abnormal Baseline ECG             0             0             0             1             0
No Longer Met Inc/Exc Criteria             1             1             1             0             0
Not Completed/Entered Extn             5             1             6             4             3
Study Terminated             3             0             3             3             1
Lost to Follow-up             3             1             0             2             5
Withdrawal by Subject             4             7             4             7             2
Pregnancy             1             0             0             0             0
Patient Uncooperative             0             0             0             1             0
Abnormal Prestudy Labs             0             0             0             0             2
Abnormal Baseline ECG             0             0             1             1             0
No Attack Pretreatment             3             5             5             6             4
No Longer Met Inc/Exc Criteria             1             0             0             0             0
Inc/Exc Criteria Not Met             0             0             1             0             0
[1]
Patients who were allocated study drug
[2]
Patients who took study drug
[3]
Patients who did not take study drug
[4]
Patients who took study drug and completed the study
Arm/Group Title Placebo/Rizatriptan/Rizatriptan/Rizatriptan Rizatriptan/Placebo/Rizatriptan/Rizatriptan Rizatriptan/Rizatriptan/Placebo/Rizatriptan Rizatriptan/Rizatriptan/Rizatriptan/Placebo Rizatriptan/Rizatriptan/Rizatriptan/Rizatriptan Total
Hide Arm/Group Description Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches) Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches) Rizatriptan 10 mg/Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches) Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Placebo = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches) Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches) Total of all reporting groups
Overall Number of Baseline Participants 83 82 84 77 81 407
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 83 participants 82 participants 84 participants 77 participants 81 participants 407 participants
41.1  (9.6) 41.0  (9.8) 42.3  (10.6) 39.5  (10.1) 38.9  (10.8) 40.6  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 82 participants 84 participants 77 participants 81 participants 407 participants
Female
68
  81.9%
71
  86.6%
72
  85.7%
63
  81.8%
67
  82.7%
341
  83.8%
Male
15
  18.1%
11
  13.4%
12
  14.3%
14
  18.2%
14
  17.3%
66
  16.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 83 participants 82 participants 84 participants 77 participants 81 participants 407 participants
Caucasian 76 75 80 72 79 382
Oriental 0 0 0 1 1 2
Black 3 2 2 2 1 10
Asian 1 1 0 0 0 2
Thai 0 1 0 0 0 1
Other 3 3 2 2 0 10
Baseline Severity (First Attack)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 83 participants 82 participants 84 participants 77 participants 81 participants 407 participants
Grades 0, 1: No pain, Mild, or Missing 1 1 0 2 0 4
Grade 2: Moderate 58 66 69 46 64 303
Grade 3: Severe 24 15 15 29 17 100
[1]
Measure Description: Each patient rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain)
1.Primary Outcome
Title Pain Relief at 2 Hours During the First Migraine Attack Period
Hide Description Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) at baseline to grades 0 or 1 (no headache or mild) at 2 hours after initial dosing for the first migraine attack
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase.
Arm/Group Title Rizatriptan 10 mg Placebo
Hide Arm/Group Description:
All Rizatriptan 10 mg patients from all Treatment Sequences
All Placebo patients from all Treatment Sequences
Overall Number of Participants Analyzed 320 82
Measure Type: Number
Unit of Measure: participants
Reporting pain relief 246 30
Not reporting pain relief 74 52
2.Secondary Outcome
Title Pain Relief at 2 Hours During the Second Migraine Attack Period
Hide Description Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the second migraine attack
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next.
Arm/Group Title Rizatriptan 10 mg Placebo
Hide Arm/Group Description:
All Rizatriptan 10 mg patients from all Treatment Sequences
All Placebo patients from all Treatment Sequences
Overall Number of Participants Analyzed 291 73
Measure Type: Number
Unit of Measure: Participants
Reporting pain relief 228 27
Not reporting pain relief 63 46
3.Secondary Outcome
Title Pain Relief at 2 Hours During the Third Migraine Attack Period
Hide Description Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the third migraine attack
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next.
Arm/Group Title Rizatriptan 10 mg Placebo
Hide Arm/Group Description:
All Rizatriptan 10 mg patients from all Treatment Sequences
All Placebo patients from all Treatment Sequences
Overall Number of Participants Analyzed 259 75
Measure Type: Number
Unit of Measure: Participants
Reporting pain relief 207 21
Not reporting pain relief 52 54
4.Secondary Outcome
Title Pain Relief at 2 Hours During the Fourth Migraine Attack Period
Hide Description Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the fourth migraine attack
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next.
Arm/Group Title Rizatriptan 10 mg Placebo
Hide Arm/Group Description:
All Rizatriptan 10 mg patients from all Treatment Sequences
All Placebo patients from all Treatment Sequences
Overall Number of Participants Analyzed 255 57
Measure Type: Number
Unit of Measure: Participants
Reporting pain relief 190 31
Not reporting pain relief 65 26
Time Frame During the 24 hours treatment period, and up to and including 7 days after the last dose of study therapy.
Adverse Event Reporting Description

Although a patient may have had two or more adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.

The subjects reported at risk are subjects with follow-up after at least one dose of study drug.

 
Arm/Group Title Rizatriptan 10 mg Placebo
Hide Arm/Group Description All Rizatriptan 10 mg patients from all Treatment Sequences All Placebo patients from all Treatment Sequences
All-Cause Mortality
Rizatriptan 10 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rizatriptan 10 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/337 (0.00%)   0/84 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Rizatriptan 10 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   199/323 (61.61%)   31/84 (36.90%) 
Blood and lymphatic system disorders     
Leukocytes Decreased * 1  4/323 (1.24%)  0/84 (0.00%) 
Cardiac disorders     
Palpitation * 1  4/323 (1.24%)  0/84 (0.00%) 
Tachycardia * 1  4/323 (1.24%)  0/84 (0.00%) 
Endocrine disorders     
Hypothyroidism * 1  0/323 (0.00%)  1/84 (1.19%) 
Eye disorders     
Depth Perception Loss * 1  0/323 (0.00%)  1/84 (1.19%) 
Gastrointestinal disorders     
Diarrhea * 1  3/323 (0.93%)  1/84 (1.19%) 
Dry Mouth * 1  11/323 (3.41%)  1/84 (1.19%) 
Nausea * 1  23/323 (7.12%)  2/84 (2.38%) 
Vomiting * 1  5/323 (1.55%)  1/84 (1.19%) 
General disorders     
Asthenia/Fatigue * 1  17/323 (5.26%)  0/84 (0.00%) 
Chills * 1  0/323 (0.00%)  1/84 (1.19%) 
Fever * 1  1/323 (0.31%)  1/84 (1.19%) 
Pain, Abdominal * 1  5/323 (1.55%)  0/84 (0.00%) 
Pain, Chest * 1  11/323 (3.41%)  1/84 (1.19%) 
Accommodation Disorder * 1  0/323 (0.00%)  1/84 (1.19%) 
Infections and infestations     
Candidiasis * 1  0/323 (0.00%)  1/84 (1.19%) 
Infection, Respiratory, Upper * 1  2/323 (0.62%)  2/84 (2.38%) 
Investigations     
Alanine Amino Transferase (ALT) Increased * 1  4/323 (1.24%)  0/84 (0.00%) 
Nervous system disorders     
Abnormal Sensation * 1  2/323 (0.62%)  1/84 (1.19%) 
Ataxia * 1  0/323 (0.00%)  1/84 (1.19%) 
Dizziness * 1  29/323 (8.98%)  4/84 (4.76%) 
Headache * 1  6/323 (1.86%)  1/84 (1.19%) 
Hypesthesia * 1  2/323 (0.62%)  1/84 (1.19%) 
Mental Acuity Decreased * 1  6/323 (1.86%)  2/84 (2.38%) 
Nervousness * 1  1/323 (0.31%)  1/84 (1.19%) 
Paresthesia * 1  13/323 (4.02%)  0/84 (0.00%) 
Somnolence * 1  28/323 (8.67%)  4/84 (4.76%) 
Psychiatric disorders     
Euphoria * 1  5/323 (1.55%)  0/84 (0.00%) 
Reproductive system and breast disorders     
Hot Flashes * 1  2/323 (0.62%)  1/84 (1.19%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea * 1  4/323 (1.24%)  0/84 (0.00%) 
Skin and subcutaneous tissue disorders     
Flushing * 1  7/323 (2.17%)  1/84 (1.19%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CRISP Dictionary
Pooled Extension data for PN022- NCT00897949; PN025- NCT00899379 and PN029- NCT00897104 appears in NCT00897949
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00899379     History of Changes
Other Study ID Numbers: 0462-025
MK0462-025
2009_590
First Submitted: May 8, 2009
First Posted: May 12, 2009
Results First Submitted: September 26, 2009
Results First Posted: July 15, 2010
Last Update Posted: April 3, 2015